As a clinician it is not always clear what and how new medical devices get approved. Patients are often ahead of the curve especially if they have a chronic disease. A combination of frustration at the industry not moving fast enough and patient knowledge can lead to movements such as the #wearenotwaiting movement in diabetes. Sharing of opensource code has led individuals to set up DIY pancreas systems hacking into commercial insulin pumps. However, these are not licensed and have not passed the test required by the FDA in the USA, nor do they have the CE mark required in the EU.
In the EU, the European Commission has set out to harmonise the interpretations of previous legislation which had differed according to different countries by bringing in new regulations which will be phased in between now and May 2022. For the non-specialist this means stricter pre-market controls and and EU wide database to pick up any post-sale problems with device ID cards to increase traceability. A group of European level specialists will need to authorise sales of new devices (which can include software) with a conformity assessment being carried out and clinical trials will be more strictly controlled. During the conformity assessment both the performance of the device plus the technical aspects are revised and audited. The regulation is also being expanded to cover more medical devices not previously included such as coloured contact lenses.
In the USA the FDA is in charge of clearing medical devices which have to have proven scientific value. Of note is the section of devices covered by the HUD or Humanitarian Use Device in which refers to devices for conditions affecting fewer than 4000 individuals in the USA per year. The traditional route which drugs currently have to undergo takes up to 10 years includes 4 phases of discovery & development, preclinical research, clinical research with 4 levels of trials, and finally an FDA review before any product can hit the market. This is obviously not going to be a viable option even for drugs in the future.
Artificial intelligence is throwing up new challenges to all regulatory authorities. The fact that artificial intelligence and machine learning inherently change all the time reacting to the data being processed lead to traditional pre and post-marketing checks becoming redundant. Although still in the consultation process the FDA would be looking at needing to be updated when algorithms change. As these algorithms are often the magic in the box which separates one manufacturer from another it will be interesting to see how commercial interests will align with safety regulations. Perhaps the future will be in more reactive regulations and more emphasis on analysing post-marketing data. This may mean limited approval in exchange for more detailed and personalised monitoring of patients using their own wearables and cloud info.